Phase 2a Study of Efficacy and Safety of OpSCF in Moderate to Severe Atopic Dermatitis
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the efficacy and safety of a monoclonal antibody, OpSCF, in the treatment of adults with moderate to severe Atopic Dermatitis (Eczema). OpSCF will be compared to a placebo.
OpSCF or placebo will be administered every 2 weeks for 14 weeks, and the efficacy will be assessed two weeks later. After that, subjects may choose to enter an Open Label Extension phase in which all subjects will receive OpSCF every 4 weeks for 40 additional weeks.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: OpSCF OpSCF, 600 mg, subcutaneously, every two weeks x 14 weeks |
Biological: OpSCF
Monoclonal Antibody
|
| Placebo Comparator: Placebo Matched placebo, subcutaneously, every two weeks x 14 weeks |
Biological: Placebo
Formulation buffer without active agent
|
| Active Comparator: Open Label Extension Subjects may choose to continue in an Open Label Extension (OLE) phase if they complete the randomized phase. All subjects regardless of treatment assignment in the randomized phase will receive OpSCF, 600 mg every 4 weeks for up to 36 weeks. |
Biological: OpSCF
Monoclonal Antibody
Biological: OpSCF (Open Label Extension)
Subjects may continue on an Open Label Extension after completing the 16-week randomized portion of the study
|
Outcome Measures
Primary Outcome Measures
- Percent change in Eczema Area and Severity Index (EASI) score from baseline at Week 16 [16 weeks]
Validated measure of activity of atopic dermatitis. A score of 0 indicates clear or no eczema, 0.1 to 1.0 indicates almost clear, 1.1 to 7 indicates mild disease, 7.1 to 21 indicates moderate disease, 21.1 to 50 indicates severe disease, and greater than 51 indicates very severe disease.
Secondary Outcome Measures
- Incidence of AEs and SAEs [Through study completion, approximately 1 year including the open label extension phase]
Safety
- Proportion of subjects achieving at least a 2-grade reduction from baseline to clear (0) or almost clear (1) in vIGA-AD [16 weeks]
Validated Investigator scoring of AD activity
- Change and percent change from baseline in weekly average of the daily Peak Pruritus Numerical Rating Scale (PP-NRS) [16 weeks]
Validated scale of subject-reported itch. The Peak Pruritus Numerical Rating Scale is a single self-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours based on the following question: 'On a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".
Other Outcome Measures
- Change from baseline in blood biomarkers and IgE at Weeks 4, 8, 12, and 16 [16 weeks]
Blood tests
- Change from baseline in skin biomarkers collected using skin biopsies at Weeks 4 and 16 (optional for consenting subjects) [16 weeks]
Histopathological examination
- Change from baseline in skin biomarkers collected using tape strips at Weeks 4 and 16 (optional for consenting subjects) [16 weeks]
Analysis of proteomics and mRNA levels
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject has clinically confirmed diagnosis of active AD
-
Subject has at least a 6-month history of AD
-
Subject is willing to use effective birth control
Exclusion Criteria:
-
Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
-
Subject has any clinically significant medical condition that would put the subject at undue risk or interfere with interpretation of study results.
-
Subject has used dupilumab within 26 weeks prior to Day 1
-
Subject has used tralokinumab within 12 weeks prior to Day 1
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cahaba Dermatology & Skin Health Center | Birmingham | Alabama | United States | 33607 |
| 2 | Unison Clinical Trials | Sherman Oaks | California | United States | 91403 |
| 3 | Skin Care Research | Boca Raton | Florida | United States | 33456 |
| 4 | RM Medical Research | Miami Lakes | Florida | United States | 33014 |
| 5 | Skin Research of South Florida | Miami | Florida | United States | 33173 |
| 6 | Advanced Clinical Research Institute | Tampa | Florida | United States | 33607 |
| 7 | Arlington Dermatology | Rolling Meadows | Illinois | United States | 60008 |
| 8 | Options Research Group | West Lafayette | Indiana | United States | 47906 |
| 9 | Oakland Hills Dermatology P.C | Auburn Hills | Michigan | United States | 48326 |
| 10 | Skin Cancer and Dermatology Institute | Reno | Nevada | United States | 89509 |
| 11 | Forest Hills Dermatology Group | Kew Gardens | New York | United States | 11415 |
| 12 | DermEdge Research Inc | Mississauga | Ontario | Canada | L4Y 4C5 |
| 13 | Oshawa Clinic Dermatology Trials | Oshawa | Ontario | Canada | L1H 1B9 |
| 14 | Research Toronto | Toronto | Ontario | Canada | M4W 2N2 |
| 15 | Innovaderm Research Inc | Montréal | Quebec | Canada | H2X 2V1 |
| 16 | Centre de Recherche Saint-Louis | Québec City | Quebec | Canada | G1W 4R4 |
Sponsors and Collaborators
- Opsidio, LLC
- Innovaderm Research Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OpSCF-201